MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS STANDARD CRANIOTOME, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME

Catalog Number B-GREEN

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

It was reported that during engineering evaluation, it was discovered that the craniotome device had "a damaged neuro tip and was overheating".This event was not related to surgery.There were no injuries or medical intervention or prolonged hospitalization associated with this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual sample was returned for evaluation.Reliability engineering evaluated the device and discovered the device had "a damaged neuro tip and was overheating".The assignable root cause was determined to be due to normal wear over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STANDARD CRANIOTOME, BLACK MAX
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 3647900
• MDR Text Key: 4200709
• Report Number: 1045834-2014-11516
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-GREEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1